Preventing blood clots in critically ill children using enoxaparin
Age-dependent Heterogeneity in the Efficacy of Prophylaxis With Enoxaparin Against Catheter-associated Thrombosis in Critically Ill Children
This study is testing if giving enoxaparin to critically ill children aged 1-17 can help prevent blood clots related to central venous catheters better than the usual care.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 258 (estimated) |
| Ages | N/A to 17 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 22 sites (Birmingham, Alabama and 21 other locations) |
| Trial ID | NCT04924322 on ClinicalTrials.gov |
What this trial studies
The CRETE Studies aim to evaluate the effectiveness of enoxaparin, an anticoagulant, in preventing central venous catheter-associated deep venous thrombosis (CADVT) in critically ill children. This study recognizes the age-dependent differences in how children respond to this medication, particularly focusing on those aged 1-17 years. By comparing early administration of enoxaparin to standard care, the study seeks to confirm its efficacy and safety in reducing the risk of CADVT. The research is crucial as pediatric venous thromboembolism has significantly increased in recent years, and current prophylactic measures are limited due to a lack of age-specific evidence.
Who should consider this trial
Good fit: Ideal candidates for this study are critically ill children aged over 36 weeks corrected gestational age to under 17 years who have had an untunneled central venous catheter inserted within the last 24 hours.
Not a fit: Patients with recent bleeding complications, major trauma, or those currently on anticoagulant therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of blood clots in critically ill children, improving their overall health outcomes.
How similar studies have performed: Previous studies have shown promising results with enoxaparin in adult populations, but this approach in pediatric patients is novel and underexplored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria 1. \>36 weeks corrected gestational to \<17 years old 2. \<24 hours after insertion of an untunneled CVC 3. CVC inserted in the internal jugular or femoral vein Exclusion criteria 1. Radiologic diagnosis of CADVT in the site of insertion in prior 6 weeks 2. Currently receiving an antithrombotic agent, e.g., LMWH, UFH, warfarin and aspirin, but not UFH at dose to maintain patency of a vascular catheter 3. Presence of clinically relevant bleeding, i.e., hemoglobin decreased ≥2 g/dl in 24 hours, required medical or surgical intervention to restore hemostasis, or in the retroperitoneum, pulmonary, intracranial or central nervous system, in the prior 60 days 4. Surgery in the prior 7 days 5. Major trauma in the prior 7 days 6. Presence of coagulopathy, i.e., INR \>2.0, aPTT \>50 seconds or platelet count \<50 x 10\^3/mcL 7. Presence of renal failure, i.e., creatinine clearance \<30 mL/min/1.73 m2 8. Known hypersensitivity to heparin or pork products 9. Laboratory confirmed HIT 10. Current pregnancy or lactation 11. Presence of an epidural catheter 12. Limitation of care 13. Previous enrollment in the CRETE Studies
Where this trial is running
Birmingham, Alabama and 21 other locations
- Children's of Alabama — Birmingham, Alabama, United States (Recruiting)
- Arkansas Children's Hospital — Little Rock, Arkansas, United States (Recruiting)
- Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
- Yale-New Haven Children's Hospital — New Haven, Connecticut, United States (Recruiting)
- University of Florida -UF Health — Gainesville, Florida, United States (Recruiting)
- Johns Hopkins All Children's — St. Petersburg, Florida, United States (Recruiting)
- Children's Hospital of Illinois at OSF Saint Francis Medical Center — Peoria, Illinois, United States (Recruiting)
- Stead Family Children's Hospital — Iowa City, Iowa, United States (Recruiting)
- Children's Hospital St. Louis — St Louis, Missouri, United States (Recruiting)
- Hassenfeld Children's Hospital — New York, New York, United States (Recruiting)
- New York Presbyterian Hospital — New York, New York, United States (Recruiting)
- Golisano Children's Hospital — Rochester, New York, United States (Recruiting)
- Maria Fareri Children's Hospital — Valhalla, New York, United States (Recruiting)
- UH Rainbow Babies & Children's Hospital — Cleveland, Ohio, United States (Recruiting)
- Nationwide Children's Hospital — Columbus, Ohio, United States (Withdrawn)
- University of Oklahoma — Oklahoma City, Oklahoma, United States (Recruiting)
- Penn State Hershey Children's Hospital — Hershey, Pennsylvania, United States (Recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- Dell Children's Medical Canter — Austin, Texas, United States (Recruiting)
- UTSW Medical Center; Children's Medical Center of Dallas — Dallas, Texas, United States (Recruiting)
- Children's Hospital of Richmond — Richmond, Virginia, United States (Withdrawn)
- Children's Hospital Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: E. Vincent Faustino, MD, MHS — Associate Professor of Pediatrics, Yale School of Medicine
- Study coordinator: E. Vincent Faustino, MD, MHS
- Email: vince.faustino@yale.edu
- Phone: 203-785-4651
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.